11 August 2016
“Completing our IPO in June provided the financial resources to continue our clinical efforts in administering drug therapies through the suprachoroidal space for the treatment of patients suffering from sight-threatening diseases,” said
Clearside Business Highlights
Patients in the Phase 2 clinical trial (TANZANITE) “active arm” achieved 19 letters of improvement in Best Corrected Visual Acuity (BCVA) at the end of the three-month trial observation period as compared to 11 letters of improvement in the “control arm”. Seventy eight percent (78%, or 18/23) of patients in the active arm of the trial did not require additional intravitreal Eylea® treatments during the three-month trial compared to 30% (7/23) in the control arm (p=0.003).
Clearside received net proceeds of approximately
Clearside selected axitinib as the lead compound for its development program for the treatment of wet AMD through suprachoroidal administration. Clearside is developing a proprietary suspension formulation of axitinib and plans to submit to the
Second Quarter 2016 Financial Results
Clearside’s research and development expenses were
General and administrative expenses were
Cash and cash equivalents totaled
Net losses attributable to common stockholders for the quarter ended
About
Cautionary Note Regarding Forward Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Clearside’s product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Clearside’s Registration Statement on Form S-1 (File No. 333-208916) declared effective by the
Financials
CLEARSIDE BIOMEDICAL, INC. | ||||||||||||||||
Selected Financial Data | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Statements of Operations Data | Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
License revenue | $ | 5 | $ | — | $ | 510 | $ | — | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 4,213 | 2,147 | 8,802 | 4,655 | ||||||||||||
General and administrative | 970 | 3,023 | 2,243 | 4,272 | ||||||||||||
Total operating expenses | 5,183 | 5,170 | 11,045 | 8,927 | ||||||||||||
Loss from operations | (5,178 | ) | (5,170 | ) | (10,535 | ) | (8,927 | ) | ||||||||
Other income (expense) | 76 | (67 | ) | (16 | ) | (67 | ) | |||||||||
Net loss | $ | (5,102 | ) | $ | (5,237 | ) | $ | (10,551 | ) | $ | (8,994 | ) | ||||
Net loss per share of common stock — basic and diluted | $ | (0.62 | ) | $ | (2.36 | ) | $ | (1.94 | ) | $ | (4.46 | ) | ||||
Weighted average shares outstanding — basic and diluted | 8,243,864 | 2,216,755 | 5,452,105 | 2,018,325 |
Balance Sheet Data | June 30, 2016 |
December 31, 2015 |
|||||
Cash and cash equivalents | $ | 55,279 | $ | 20,283 | |||
Total assets | 56,164 | 21,055 | |||||
Deferred revenue | 190 | 700 | |||||
Long-term debt (including current portion) | 5,686 | 5,976 | |||||
Total liabilities | 10,268 | 10,400 | |||||
Accumulated deficit | (49,914 | ) | (39,363 | ) | |||
Total stockholders’ equity (deficit) | 45,896 | (36,659 | ) |
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